COmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis (CONCERTO)

Phase 1

Completed

• Conditions: Arteriovenous Fistula Stenosis
• Interventions: Device: Angioplasty

• Registration Number: NCT05961852
• Lead Sponsor: Singapore General Hospital

Brief Summary

To evaluate the preliminary efficacy of combination of cutting and drug-coated balloon for the treatment of resistant AVF stenosis.

Detailed Description

This is a single arm pilot study recruiting 19 participants with resistant AVF stenosis (defined as having \> 30% residual stenosis after optimal balloon angioplasty) to receive cutting and drug-coated balloon.

The outcome measure is target lesion primary patency at 6 months. Outcome will be clinically driven.

Study Timeline

• Study Start: 2018-08-15
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2023-07
• Study First Submitted: 2023-07-17
• Study First Submitted QC: 2023-07-17
• Last Update Submitted: 2023-07-17
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

1. Failing mature upper limb AVF
2. Resistant stenosis (>30% residual stenosis) after optimal conventional balloon angioplasty (appropriately sized balloon, inflated up to rated burst pressure, at least twice for at least a minute per inflation)
3. Patient is >= 21 years of age
4. Ability to provide informed consent

Exclusion Criteria

1. Thrombosed AVF
2. Target lesion has a sharp angle (> 45 degrees)
3. Lesions requiring cutting balloon size > 7 mm
4. Coagulopathy or thrombocytopaenia that cannot be adequately managed for the procedure
5. Contraindication to dual antiplatelet therapy
6. Severe allergy to contrast media that cannot be adequately managed for the procedure
7. Breast-feeding and/or pregnant females
8. Male patients who are planning to father children during the trial period
9. Unable to comply with follow up protocol (for instance, limited life expectancy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	Angioplasty	Cutting and drug-coated balloon angioplasty

Primary Outcome Measures

Name	Time	Method
Target lesion primary patency	6 months after index procedure	Time from index treatment to repeat treatment of target lesion or thrombosis of circuit.

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore